Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
A Randomized, Comparative Multicenter Clinical Trial Evaluating BST-CarGel™ and Microfracture in Repair of Focal Articular Cartilage Lesions on the Femoral Condyle
1 other identifier
interventional
80
3 countries
18
Brief Summary
This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone. Furthermore, the effect of BST-CarGel in decreasing cartilage related pain and improving cartilage-related function in the knee will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2005
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
December 18, 2015
CompletedDecember 18, 2015
December 1, 2015
5.2 years
April 11, 2006
November 5, 2015
December 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.
Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.
12 months
Repair Cartilage T2 Relaxation Time
Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).
12 months
Secondary Outcomes (2)
Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)
12 months
Frequency of Adverse Events Between Study Groups
12 months
Study Arms (2)
Microfracture with BST-CarGel
EXPERIMENTALBST-CarGel applied to a Microfractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Microfracture without BST-CarGel
ACTIVE COMPARATORMicrofractured lesion in repair of focal articular cartilage lesions on the femoral condyle
Interventions
Microfracture performed with BST-CarGel added to the treated defect
Microfracture performed without BST-CarGel added to the treated defect.
Eligibility Criteria
You may qualify if:
- Between 18 and 55 years of age
- Focal articular cartilage lesion on the medial femoral condyle
- Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion
- Stable knee
You may not qualify if:
- Multiple lesions or kissing lesions
- Clinically relevant compartment malalignment (\> 5 degrees)
- Undergone ligament treatments in the affected knee within 2 years prior to trial
- Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
- Previous surgical cartilage treatments in the affected knee in the last 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Sports Medicine Centre - University of Calgary
Calgary, Alberta, T2N 1N4, Canada
New West Sports Medicine
New Westminster, British Columbia, V3L 5P5, Canada
Hospital at UBC
Vancouver, British Columbia, V6T 1Z3, Canada
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4, Canada
Orthopaedic and Sport Medicine Clinic of Nova Scotia
Halifax, Nova Scotia, B3H 4M2, Canada
Entralogix Clinical Group Inc.
Newmarket, Ontario, V6T 2B5, Canada
Sports Medicine Clinic - Carleton University
Ottawa, Ontario, K1S 5B6, Canada
Sunnybrook Health Sciences Centre, Div. of Orthopaedic Surgery
Toronto, Ontario, M3N 3M5, Canada
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Hospital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5, Canada
Centre Hospitalier Affilie Universitaire de Quebec et Hôpital Valcartier
Québec, Quebec, G1J 1Z4, Canada
Seoul National University Hospital
Seoul, 110-744, South Korea
Kyung Hee University Medical Center
Seoul, 130-702, South Korea
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital Universitario Gregorio Maraňón
Madrid, Madrid, 28034, Spain
Hospital La Paz
Madrid, Madrid, Spain
FREMAP Centro de Prevención y Rehabilitación
Majadahonda, Madrid, 28220, Spain
Hospital Begona de Gijon
Gijón, Principality of Asturias, 33204, Spain
Related Publications (4)
Hoemann CD, Hurtig M, Rossomacha E, Sun J, Chevrier A, Shive MS, Buschmann MD. Chitosan-glycerol phosphate/blood implants improve hyaline cartilage repair in ovine microfracture defects. J Bone Joint Surg Am. 2005 Dec;87(12):2671-2686. doi: 10.2106/JBJS.D.02536.
PMID: 16322617BACKGROUNDChevrier A, Hoemann CD, Sun J, Buschmann MD. Chitosan-glycerol phosphate/blood implants increase cell recruitment, transient vascularization and subchondral bone remodeling in drilled cartilage defects. Osteoarthritis Cartilage. 2007 Mar;15(3):316-27. doi: 10.1016/j.joca.2006.08.007. Epub 2006 Sep 26.
PMID: 17008111BACKGROUNDHoemann CD, Sun J, McKee MD, Chevrier A, Rossomacha E, Rivard GE, Hurtig M, Buschmann MD. Chitosan-glycerol phosphate/blood implants elicit hyaline cartilage repair integrated with porous subchondral bone in microdrilled rabbit defects. Osteoarthritis Cartilage. 2007 Jan;15(1):78-89. doi: 10.1016/j.joca.2006.06.015. Epub 2006 Aug 8.
PMID: 16895758BACKGROUNDStanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.
PMID: 24048551RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alberto Restrepo, MD, Director of Medical and Clinical Affairs
- Organization
- Piramal Healthcare (Canada) Limited
Study Officials
- PRINCIPAL INVESTIGATOR
William Stanish, MD
Orthopaedic and Sport Medicine - Dalhousie University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2006
First Posted
April 13, 2006
Study Start
December 1, 2005
Primary Completion
February 1, 2011
Study Completion
May 1, 2011
Last Updated
December 18, 2015
Results First Posted
December 18, 2015
Record last verified: 2015-12